A booming medical industry in the US is almost totally unregulated

More American children conceived through in vitro fertilization
were born in 2013 than ever before, an estimated 1.5% of all
births, according to data from the Centers for Disease
Control and Prevention. And most of those procedures were
done with little oversight.

The number of IVF cycles done in the United States
increased by 28% from 2003 to 2012, and that rising
trend has spiked in recent years. Based on preliminary data, the
number of IVF cycles increased by 21% in just one year,
from 2012 to 2013.

IVF is a procedure in which eggs are taken from a woman's ovaries
and fertilized with sperm in a petri dish. Then one or more
fertilized embryos are placed in the woman's uterus, where one
will hopefully implant and grow into a baby.

The CDC collects and publishes data about IVF, as required by the
Fertility Clinic Success Rate and Certification Act passed in
1992, but not all
clinics report their data to the CDC, only limited data about
IVF outcomes are reported, and there are no official guidelines
limiting which procedures can be done.

This level of government oversight leaves the industry to
regulate itself for the most part, deciding on its own what
procedures are appropriate to perform for patients.

Every clinic that performs IVF is invited to belong to SART,
Dr. Pasquale Patrizio of the Yale School of Medicine's
fertility center told Business Insider. Over 90% of fertility
clinics are members, according to the organization's website.
To remain in good standing with SART, clinics must report
data about the procedures they do and follow the recommendations
it issues.

SART collects information about why patients sought infertility
treatments, whether the eggs or embryos used in IVF were donated
or frozen, whether certain procedures were used beyond
traditional IVF (like
intracytoplasmic sperm injection, when scientists insert
sperm into an egg to fertilize it instead of mixing them in
a petri dish), how many embryos were transferred per IVF
cycle, the percentage of cycles that resulted in pregnancies and
live births, and the percentage of births that were twins or
multiples.

SART collects data on how many IVF
cycles used frozen eggs or embryos.

SART makes this data from individual clinics available online, along with
national averages.

Practice committees for the ASRM and SART write reports and opinions on
various aspects of assisted reproduction, like what new
procedures, treatments, or knowledge are emerging and when they
should be applied.

For example, the practice committees have recommendations in
place for how many embryos should be transferred per cycle
depending on the age of the woman doing IVF, based on their own
collected data and other scientific publications.

Doctors, however, are not obliged to follow these
recommendations. New procedures do not have to be approved before
they can be performed in clinics.

For clinics that belong to SART, "somebody is watching over your
shoulder," Patrizio told Business Insider. Plus, labs that deal
with human eggs, sperm, and embryos are subject to Food and Drug
Administration oversight, like other labs that work with human
tissue — but only in that they must comply
with measures to prevent the spread of disease.

Clinics do have incentive to provide quality service to patients
and stay in good standing with SART to maintain their reputations
and avoid malpractice suits, but doing anything the organization
recommends is completely voluntary. If clinics don't comply
with SART guidelines about procedures, they receive a letter from
the organization, Patrizio said.

The
CDC collects and publishes data on how IVF cycles turn out at
clinics that report their data.CDC

Historically, it's been
illegal for the National Institutes of Health to fund
research on human embryos. (A ban in place since the late
1990s has softened somewhat under
the Obama Administration.) Without government money for
research, IVF was developed in private clinics where the focus
was on providing services to patients, not doing research first.

Now the industry decides itself what new procedures can be
done on patients, which is "pretty unique," according to
Annas.

"It's pretty loose out there," he said.

Where that leaves us

So what does this mean for the thousands who get assisted
reproduction treatments in the US every year?

It means that fertility clinics can offer treatments to patients
for purposes that ASRM and SART have not approved, with no clear
repercussions.

For an example, look no further than elective egg freezing. The
ASRM and SART practice committees only announced egg freezing
isn't an experimental procedure anymore in 2013, and they still
don't recommend it for women who are healthy and fertile but want
to delay having kids until they might have more difficulty
getting pregnant. They only recommend egg freezing for women
who face the prospect of infertility because they
need chemotherapy or another essential treatment that
damages the ovaries.

"To only have the industry monitoring itself is not necessarily
proving to be the best case scenario for the health of women and
children," she said.

It's good that the assisted fertility industry does have some
oversight and guidance from professional organizations, with
leeway for doctors to make decisions based on the particular
needs of individual patients, but there are significant questions
about whether that some is enough.